AzTrials
AzTrials

Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)Phase 4GUIDE-HBRNCT06763744

Genotype-Guided Abbreviated DAPT Versus Un-Guided De-escalation Therapy in Patients With ACS and HBR

A Phase 4 study testing P2Y12 antagonist monotherapy and clopidogrel + aspirin in people with Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI) and High Bleeding Risk, run by Samsung Medical Center at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The aim of this study is to assess the safety and efficacy of the CYP2C19 genotype-guided abbreviated dual antiplatelet therapy (DAPT) strategy versus the un-guided stepwise intensity de-escalation of DAPT strategy in patients with acute coronary syndrome (ACS) and high bleeding risk (HBR) undergoing percutaneous… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
P2Y12 antagonist monotherapy and clopidogrel + aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
1 siteSouth Korea
Study dates
1 Jun 2025to 31 Dec 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be at least 19 years of age
  • Patients who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
  • Patients presenting with ACS (ST-elevation myocardial infarction [STEMI] or non-ST-elevation [NSTE] ACS).
  • Patients with at least one lesion with equal or greater than 50% diameter stenosis requiring treatment with drug-eluting stents in native coronary artery or graft.
  • Patients with high bleeding risk (by ARC-HBR definition or PRECISE-DAPT score 25 or more)

Who cannot join

  • Patients unable to provide consent.
  • Patients who need chronic anti-coagulation therapy.
  • Patients suffering from cardiogenic shock or cardiac arrest
  • Patients with known intolerance to aspirin, all P2Y12 inhibitors, or components of drug-eluting stents.
  • Clinically significant out of range values for platelet count (< 50,000/mm3) or hemoglobin (<8 g/dL) at screening
  • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Joo-Yong Hahn, MD, PhD contact

82-2-3410-3419

jyhahn@skku.edu

Ki Hong Choi, MD, PhD contact

82-2-3410-6653

cardiokh@gmail.com

South Korea1 site

  • Samsung Medical Center

    Seoul, 06351

    Joo-Yong Hahn, MD, PhD, 82-2-3410-3419, jyhahn@skku.edu

    Ki Hong Choi, 82-2-3410-6653, cardiokh@gmail.com

Other trials in South Korea

About this study

Official title: SMart Angioplasty Research Team- Genotype-Guided Abbreviated DUal AntIplatelet Therapy Versus Un-Guided De-escalation Therapy in Patients With Acute Coronary SyndromE and High Bleeding Risk (SMART-GUIDE-HBR)

The aim of this study is to assess the safety and efficacy of the CYP2C19 genotype-guided abbreviated dual antiplatelet therapy (DAPT) strategy versus the un-guided stepwise intensity de-escalation of DAPT strategy in patients with acute coronary syndrome (ACS) and high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).

Read the detailed description

Current guidelines recommend reducing the duration of dual antiplatelet therapy (abbreviated DAPT) or de-escalating P2Y12 inhibitor intensity (de-escalation therapy) in patients at risk of major bleeding, even in patients with acute coronary syndromes. A network meta-analysis that indirectly compared these two strategies found that abbreviated dual antiplatelet therapy reduced major bleeding compared with de-escalated dual antiplatelet therapy.

Unlike prasugrel and ticagrelor, which are potent P2Y12 inhibitors, clopidogrel is activated in the liver via the cytochrome P450 2C19 (CYP2C19) metabolic pathway to exert its antiplatelet effects. Its use as monotherapy requires caution, given that CYP2C19 genotypes that may be resistant to clopidogrel are more prevalent in Asian populations than in Western populations.

Therefore, this study aimed to compare the clinical outcomes and confirm the efficacy and safety of an abbreviated dual antiplatelet therapy (Abbreviated DAPT, P2Y12 inhibitor monotherapy) strategy based on CYP2C19 genetic testing and a step-down DAPT strategy (De-escalation therapy) after 1 month of maintenance potent P2Y12 inhibitor-based dual antiplatelet therapy in patients at HBR who underwent PCI for ACS.

Being tested
P2Y12 antagonist monotherapy, clopidogrel + aspirin
Keywords
CYP2C19 Genotype, Acute coronary syndrome, De-escalation therapy, P2Y12 inhibitor monotherapy, High bleeding risk
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P2Y12 antagonist monotherapyDrug

    CYP2C19 genetic testing is performed before discharge after stent insertion. Depending on the test results, rapid (CYP2C19*1/*17 or *17/*17) or normal (CYP2C19*1/*1) metabolizers are treated with clopidogrel monotherapy, and intermediate or poor metabolizers (with CYP2C19*2 or *3 alleles) are treated with potent P2Y12 inhibitors (prasugrel or ticagrelor) monotherapy.

  • clopidogrel + aspirinDrug

    In this group, a potent P2Y12 inhibitor was changed to clopidogrel (un-guided) 1 month after PCI with maintenance of co-prescription of aspirin (DAPT).

Study groups in NCT06763744
Study groupRoleWhat they receive
Genotype-guided abbreviated DAPTActive comparatorRapid (CYP2C19*1/*17 or *17/*17) or normal metabolizers (CYP2C19*1/*1) for clopidogrel will receive clopidogrel monotherapy and intermediate or poor metabolizers will receive potent P2Y12 inhibitor (prasugrel or ticagrelor) monotherapy (patients carrying a CYP2C19*2 or *3 alleles) after 1 month of potent P2Y12 inhibitor based DAPT.
Receives: Drug: P2Y12 antagonist monotherapy
Un-guided de-escalation of DAPTActive comparatorA potent P2Y12 inhibitor is changed to clopidogrel 1 month after PCI, and aspirin is maintained.
Receives: Drug: clopidogrel + aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major or clinically relevant non-major bleeding

    Bleeding Academic Research Consortium type 2, 3, or 5

    Measured: 6 months after PCI

Secondary outcomes (30)

  1. Major bleeding

    BARC type 3 or 5

    Measured: 6 months after PCI

  2. Clinically relevant non-major bleeding

    BARC type 2

    Measured: 6 months after PCI

  3. Net adverse clinical event

    A composite of all-cause death, MI, stroke, stent thrombosis, and major bleeding

    Measured: 6 months after PCI

  4. Major adverse cardiac and cerebrovascular event

    A composite of all-cause death, MI, stent thrombosis, or stroke

    Measured: 6 months after PCI

  5. All-cause death

    Death from any causes

    Measured: 6 months after PCI

  6. Cardiovascular death

    Death from cardiovascular causes

    Measured: 6 months after PCI

  7. MI

    Measured: 6 months after PCI

  8. Stent thrombosis

    Definite or probable, defined by ARC

    Measured: 6 months after PCI

  9. Stroke

    Measured: 6 months after PCI

  10. Repeat revascularization

    Measured: 6 months after PCI

  11. Target vessel revascularization

    Measured: 6 months after PCI

  12. Target lesion revascularization

    Measured: 6 months after PCI

  13. A composite of cardiovascular death, MI, stent thrombosis, or stroke

    Measured: 6 months after PCI

  14. A composite of cardiovascular death, MI, stent thrombosis, stroke, or repeat revascularization

    Measured: 6 months after PCI

  15. Total medical cost

    Measured: 1 year after PCI

  16. Major or clinically relevant non-major bleeding

    Measured: 1 year after PCI

  17. Major bleeding

    Measured: 1 year after PCI

  18. Clinically relevant non-major bleeding

    Measured: 1 year after PCI

  19. Net adverse clinical event

    A composite of all-cause death, MI, stent thrombosis, stroke, and major bleeding

    Measured: 1 year after PCI

  20. Major adverse cardiac and cerebrovascular event

    A composite of all-cause death, MI, stent thrombosis, or stroke

    Measured: 1 year after PCI

  21. All-cause death

    Measured: 1 year after PCI

  22. Cardiovascular death

    Measured: 1 year after PCI

  23. MI

    Measured: 1 year after PCI

  24. Stent thrombosis

    Measured: 1 year after PCI

  25. Stroke

    Measured: 1 year after PCI

  26. Repeat revascularization

    Measured: 1 year after PCI

  27. Target vessel revascularization

    Measured: 1 year after PCI

  28. Target lesion revascularization

    Measured: 1 year after PCI

  29. A composite of cardiovascular death, MI, stent thrombosis, or stroke

    Measured: 1 year after PCI

  30. A composite of cardiovascular death, MI, stent thrombosis, stroke, or repeat revascularization

    Measured: 1 year after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, open-label, two-arm, randomized controlled trial
Masking
None (open label)
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06763744
Sponsor's protocol ID
GUIDE-HBR
Acronym
GUIDE-HBR
Status last verified
May 2025
First submitted
1 Jan 2025
Last updated
18 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing P2Y12 antagonist monotherapy and clopidogrel + aspirin in people with Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI) and High Bleeding Risk, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joo-Yong Hahn, MD, PhD (82-2-3410-3419, jyhahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major or clinically relevant non-major bleeding (time frame: 6 months after PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06763744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in